SUPPLY CHAIN ARTICLES

  • FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  • From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

    In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

  • How Can We Move RNA Forward In Our Therapeutics Arsenal?

    RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

  • Inside Alnylam's Playbook For High Volume siRNA Production

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

  • Multidisciplinary mRNA: What Can We Learn From Other CGTs?

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

SUPPLY CHAIN VIDEOS

In response to an audience poll question gauging which cGMP materials have proven the most difficult to source, our speakers provide additional clarity around which IVT & LNP-related materials today are more “commoditized”.

In this Advancing RNA Live clip, Sail Biomedicines’ Marc Wolfgang gives us a brief primer on the main differences and challenges in developing an IVT reaction for circular RNA, as opposed to linear mRNA.    

Explore the broad benefits and challenges that could be encounter by working with self-amplifying and circular RNA modalities — particularly in terms of manufacturing, raw material supply, COGS, and patient centricity.

Tune in as Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx share supply chain and manufacturing capacity constraints in the face of the urgency to address COVID-19. This is an excerpt from the Bioprocess Online Live event - mRNA Manufacturing: Bright Future, Big Challenges.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS